1. Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24-week, double-blind, randomized trial.
- Author
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Pan C, Yang W, Barona JP, Wang Y, Niggli M, Mohideen P, Wang Y, and Foley JE
- Subjects
- Acarbose adverse effects, Adamantane administration & dosage, Adamantane adverse effects, Blood Glucose metabolism, Dipeptidyl-Peptidase IV Inhibitors adverse effects, Double-Blind Method, Female, Humans, Hypoglycemic Agents adverse effects, Male, Middle Aged, Nitriles adverse effects, Pyrrolidines adverse effects, Treatment Outcome, Vildagliptin, Acarbose administration & dosage, Adamantane analogs & derivatives, Diabetes Mellitus, Type 2 drug therapy, Dipeptidyl-Peptidase IV Inhibitors administration & dosage, Hypoglycemic Agents administration & dosage, Nitriles administration & dosage, Pyrrolidines administration & dosage
- Abstract
Aims: To compare the efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor, vildagliptin, with the alpha glucosidase inhibitor, acarbose, in drug-naive patients with Type 2 diabetes., Methods: This multi-centre, randomized, double-blind, parallel-arm study compared the efficacy and tolerability of vildagliptin (100 mg daily, given as 50 mg twice daily, n = 441) and acarbose (up to 300 mg daily, given as three equally divided doses, n = 220) during 24-week treatment in drug-naive patients with Type 2 diabetes., Results: Monotherapy with vildagliptin or acarbose decreased glycated haemoglobin (HbA(1c)) (baseline approximately 8.6%) to a similar extent during 24-week treatment. The adjusted mean change from baseline to end-point (AMDelta) in HbA(1c) was -1.4 +/- 0.1% and -1.3 +/- 0.1% in patients receiving vildagliptin and acarbose, respectively, meeting the statistical criterion for non-inferiority (upper limit of 95% confidence interval for between-treatment difference < or = 0.4%). The decrease in fasting plasma glucose was similar with acarbose (-1.5 +/- 0.2 mmol/l) and vildagliptin (-1.2 +/- 0.1 mmol/l). Body weight did not change in vildagliptin-treated patients (-0.4 +/- 0.1 kg) but decreased in acarbose-treated patients (-1.7 +/- 0.2 kg, P < 0.001 vs. vildagliptin). The proportion of patients experiencing any adverse event (AE) was 35% vs. 51% in patients receiving vildagliptin or acarbose, respectively; gastrointestinal AEs were significantly more frequent with acarbose (25.5%) than vildagliptin (12.3%, P < 0.001). No hypoglycaemia was reported for either group., Conclusions: Vildagliptin is effective and well tolerated in patients with Type 2 diabetes, demonstrating similar glycaemic reductions to acarbose, but with better tolerability.
- Published
- 2008
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